One of the proven methods of enhancing hard and soft tissue regeneration is the addition of human growth factors to a wound site or surgical incision. A safe and simple way of procuring compatible growth factors in a clinical situation is by the isolation of platelets from the blood of the patient, referred to as an “autologous platelet concentrate.”
Platelets are blood cells primarily involved in arresting bleeding. However, they also contain proteins called growth factors that help promote healing and tissue regeneration. Man-made highly concentrated mixtures of platelets (platelet concentrates or Platelet rich plasma (PRP)) have higher platelet counts than natural blood and have been found to stimulate the body's soft tissue and hard tissue regeneration.
Bone marrow cell concentrate (BMCC) may include a number of target cells including the following: stem-like cells (pluripotent cells) (e.g., monocytes), white blood cells, platelets, neutrophils, lymphocytes, eosinophils, and basophils, all of which have a variety of uses in healing, regeneration, and treatment. Since it is difficult to separate any one or more of these cell fractions from a BMCC, they are typically all inserted or injected into a patient. In one embodiment, the BMCC includes platelets and white blood cells, including a stem cell fraction, where the stem cell fraction enhances the regenerative effects of the platelets.
Improved understanding of the role of growth factors as biochemical mediators of wound healing has paved the way for a new family of bioactive therapeutic products to expedite wound healing. Delivery of growth factors (recombinant or as autologous platelets) has emerged as a possible commercial opportunity for improving the clinical outcomes of soft, bone, and connective tissue repair. However, there is inability in the art to control or manipulate final product concentrations to a narrow target range, required to study or define dose-response relationships, and ultimately validate therapeutic effectiveness of these agents.
While hemoanalysis machines are capable of measuring typical platelet concentrations, they are not suitable for measuring the high platelet concentrations found in PRP transfusions. These machines are also large and expensive (e.g., $15,000-20,000/unit).
Another challenge of forming platelet and BMC concentrations is that separation and concentration procedures can prematurely activate platelets thus starting the clotting cascade. Thus, there is a need for separation procedures that avoid premature activation of platelets.